Every 8-K that Ionis Pharmaceuticals, Inc. (IONS) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow IONS and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full IONS filings page.
Ionis Pharmaceuticals (IONS) and partner Roche reported positive prespecified interim results from the Phase 3 IMAgINATION study of investigational sefaxersen in adults with primary IgA nephropathy. The study met its primary endpoint, with statistically significant and clinically meaningful proteinuria reductions versus placebo at 37 weeks, measured by 24-hour urine protein-to-creatinine ratio.
The study will continue blinded to assess kidney-function change over two years, measured by estimated glomerular filtration rate at week 105. It enrolled 459 people randomized 1:1 to sefaxersen or placebo for 105 weeks. Sefaxersen is designed as a once-monthly injection for self-administration; no new safety signals were identified. Roche licensed sefaxersen from Ionis, which received upfront, license-fee and development-milestone payments and is eligible for regulatory and sales milestones and tiered royalties on net sales.
Ionis Pharmaceuticals, Inc. (IONS) reported that its partner Novartis’ Phase 3 Lp(a)HORIZON cardiovascular outcomes trial of pelacarsen in patients with elevated lipoprotein(a) did not meet its primary endpoint of reducing major cardiovascular events versus placebo. The composite endpoint covered cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and urgent coronary revascularization requiring hospitalization.
Pelacarsen continued to show substantially lower Lp(a) levels and an acceptable safety profile, and full data are planned for presentation at an upcoming medical congress. Ionis discovered and conducted early development of pelacarsen before Novartis licensed global development and commercialization rights in 2019.
Ionis Pharmaceuticals, Inc. (IONS) announced that the U.S. FDA has approved ZANVASTRO™ (zilganersen) as the first and only disease‑modifying treatment for Alexander disease (AxD) in pediatric and adult patients. ZANVASTRO is an RNA‑targeted therapy given as a 50 mg intrathecal injection every 12 weeks to reduce glial fibrillary acidic protein (GFAP) production. The approval was supported by a pivotal global Phase 1‑3 study that met its primary endpoint, showing statistically significant and clinically meaningful stabilization of gait speed versus control at Week 61, with a favorable safety and tolerability profile. With this approval, Ionis received a Rare Pediatric Disease Priority Review Voucher and plans to launch ZANVASTRO in the U.S. in the coming weeks while partner Recordati prepares regulatory submissions in Europe and Japan, expected in 2027.
Ionis Pharmaceuticals reported Q2 2026 total revenue of $268 million, down from $452 million a year earlier, as prior-year results included a $280 million upfront payment related to a global license of sapablursen. Commercial revenue grew to $119 million, up from $103 million, driven mainly by DAWNZERA product sales and royalties from SPINRAZA and WAINUA. Product sales reached $31 million, compared with $19 million in Q2 2025.
Operating expenses rose to $370 million from $312 million, reflecting investment in launches for TRYNGOLZA and DAWNZERA and launch preparations for zilganersen. Ionis posted a GAAP net loss of $115 million versus net income of $124 million a year earlier; on a non-GAAP basis, net loss was $70 million versus non-GAAP net income of $154 million. Cash, cash equivalents and short-term investments were $2,055 million at June 30, 2026, down from $2,677 million at December 31, 2025, primarily after repayment of 0% convertible notes.
The company highlighted U.S. approval and early launch momentum for TRYNGOLZA in severe hypertriglyceridemia, DAWNZERA’s growth in hereditary angioedema, completion of enrollment in the Phase 3 REVEAL Angelman syndrome trial, and stated it remains on track to achieve its 2026 financial guidance and a goal of cashflow breakeven in 2028.
Ionis Pharmaceuticals, Inc. reaffirmed its previously announced financial guidance for the fiscal year ending December 31, 2026. The outlook remains unchanged from the financial guidance communicated on April 29, 2026 in its first quarter 2026 earnings release.
The company characterizes these expectations as forward-looking statements that involve risks and uncertainties related to discovering, developing and commercializing human therapeutics and building a business around them. It notes that actual results could differ materially if underlying assumptions do not materialize, and directs readers to its annual report for the year ended December 31, 2025 and its most recent quarterly report for a more detailed description of risks.
Ionis Pharmaceuticals reported that the CARDIO-TTRansform Phase 3 trial of eplontersen in transthyretin-mediated amyloid cardiomyopathy did not meet its primary endpoint, a composite of cardiovascular death and recurrent cardiovascular events through Week 140 versus placebo.
In patients receiving contemporary standard of care, including many on TTR stabilizers, adding eplontersen did not show a statistically significant benefit on this main outcome. A prespecified subgroup on eplontersen monotherapy showed a nominally significant hazard ratio of 0.71 for the same composite. Secondary imaging and biomarker measures generally favored eplontersen, and the drug showed large, sustained reductions in transthyretin with a safety profile consistent with prior studies. Ionis and AstraZeneca plan to present full results at the European Society of Cardiology Congress in August 2026.
Ionis Pharmaceuticals announced that the FDA has approved TRYNGOLZA (olezarsen) as the first and only treatment indicated to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG, triglycerides ≥500 mg/dL). The drug is given as a 50 mg or 80 mg once-monthly self-administered autoinjector.
The approval is based on Phase 3 CORE and CORE2 data, where TRYNGOLZA lowered fasting triglycerides by up to 72% versus placebo at six months and sustained reductions at 12 months, reduced acute pancreatitis events by up to 91%, and saw 86% of patients with baseline and 12‑month data reach triglyceride levels below 500 mg/dL. The number needed to treat over one year to prevent one acute pancreatitis episode was 20 in the overall cohort and four in the highest‑risk subgroup. TRYNGOLZA will be available for sHTG in the U.S. in July and represents Ionis’ first independent commercial launch in a prevalent condition.
Ionis Pharmaceuticals reported new clinical data for its experimental drug olezarsen in people with severe hypertriglyceridemia, a condition marked by very high blood fats. The company shared what it described as positive results from an ongoing extension of its CORE and CORE2 studies at a major lipid conference in Chicago.
The update focused on liver fat measurements using MRI technology in 53 patients who completed 12 months of treatment in the CORE open-label extension, all on an 80 mg dose of olezarsen. These patients represented about 25% of those enrolled in a dedicated liver fat substudy, which tracks hepatic fat fraction over time.
Ionis Pharmaceuticals reported governance updates and voting results from its 2026 annual stockholder meeting. The board appointed biopharmaceutical executive Ludwig Hantson, Ph.D., effective June 4, 2026. He brings more than 30 years of leadership experience at companies including Alexion, Baxter Bioscience/Baxalta, Novartis and Johnson & Johnson.
Stockholders elected directors Spencer R. Berthelsen and Joan E. Herman and approved, on an advisory basis, the compensation of named executive officers. They approved increasing the 2011 Equity Incentive Plan share authorization by 9,500,000 shares to 52,000,000 shares and expanding the Employee Stock Purchase Plan by 750,000 shares while removing its termination date. Stockholders also ratified Ernst & Young LLP as independent auditors for the 2026 fiscal year.
Ionis Pharmaceuticals reported that its partner GSK released positive pivotal Phase 3 data for bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B. Across the B-Well 1 and B-Well 2 trials, six months of treatment produced a 19% functional cure rate (233 of 1,220) in adults with baseline hepatitis B surface antigen ≤3000 IU/mL, compared with 0% in the placebo group, meeting the primary endpoints.
In patients with baseline HBsAg ≤1000 IU/mL, a key secondary endpoint showed a 26% functional cure rate (200 of 768 vs. 0 of 393 on placebo). An exploratory analysis found 49% of bepirovirsen recipients reached qHBsAg ≤100 IU/mL one year after treatment, and 23% overall (31% in the ≤1000 IU/mL subgroup) achieved sustained DNA <LLOQ at week 72. Bepirovirsen is under FDA priority review with Breakthrough and Fast Track designations and is also under review in Europe, Japan and China. Ionis is eligible for additional regulatory and sales milestone payments and tiered royalties of 10–12% on net sales.
Ionis Pharmaceuticals reported strong first quarter 2026 results and raised its full-year outlook. Total revenue rose to $246 million from $132 million a year earlier, driven by higher product sales of TRYNGOLZA and DAWNZERA and increased research and development revenue, including about $95 million of partnership milestones.
Despite the growth, Ionis recorded a GAAP net loss of $93 million, improving from a $147 million loss last year. Cash, cash equivalents and short-term investments were $1.9 billion as of March 31, 2026, with an additional $633 million held in escrow for 0% convertible notes maturing in April 2026.
Reflecting its momentum, Ionis increased 2026 total revenue guidance to $875–900 million and introduced product sales targets of $100–110 million for TRYNGOLZA and $110–120 million for DAWNZERA. The company also narrowed its expected 2026 non-GAAP operating loss to $425–475 million and reaffirmed a year-end liquidity goal of more than $1.6 billion.
Ionis Pharmaceuticals reported additional positive results from its pivotal Phase 1-3 study of zilganersen in Alexander disease, a rare and often fatal neurological disorder with no approved disease‑modifying treatments. In patients aged ≥5, zilganersen 50 mg met the study’s primary endpoint by stabilizing gait speed on the 10‑Meter Walk Test at Week 61 versus control, showing a 33.3% least‑square mean difference (p=0.041). In children aged 2‑4, Gross Motor Function Measure‑88 results suggested improved gross motor function versus control. Multiple patient, caregiver and clinician‑reported secondary endpoints generally favored zilganersen, and an exploratory analysis showed a 33.6% reduction in plasma GFAP levels at Week 61 versus control. Safety was described as favorable, with serious treatment‑emergent adverse events less frequent than in the control group. Zilganersen is under FDA Priority Review with a Prescription Drug User Fee Act action date of September 22, 2026.
Ionis Pharmaceuticals announced planned changes to its Board of Directors. Long‑serving directors B. Lynne Parshall and Joseph H. Wender will retire at the end of their current terms, with the transitions effective June 4, 2026 and aligned with the 2026 Annual Meeting of Stockholders.
On the same date, Peter N. Reikes will rejoin the board as a director. He recently served as senior strategy advisor with the Advanced Research Projects Agency for Health and earlier as senior advisor to the FDA, following a long career in healthcare investment banking and prior board service at Ionis from 2018 to 2021.
Ionis Pharmaceuticals reported fourth-quarter and full-year 2025 results and issued 2026 guidance. Full-year revenue rose to $944 million from $705 million, driven by commercial growth and R&D collaboration revenue, including a $280 million upfront payment for sapablursen licensing.
TRYNGOLZA generated $108 million in 2025 net product sales in its first launch year, helping lift commercial revenue 49% year over year. Despite this growth, the company posted a 2025 GAAP net loss of $381 million and a non-GAAP operating loss of $248 million, both improved versus 2024.
Cash, cash equivalents and short-term investments increased to $2.7 billion as of December 31, 2025, aided by convertible debt refinancing. For 2026, Ionis guides to $800–$825 million in revenue, a non-GAAP operating loss of $500–$550 million, and year-end liquidity of about $1.6 billion, while continuing to invest in multiple independent launches and a broad late-stage pipeline.
Ionis Pharmaceuticals, Inc. reported preliminary 2025 U.S. net product sales of $105 million for its drug TRYNGOLZA. These figures are unaudited, may be adjusted, and are being shared ahead of the company’s full financial results, which are planned for February 2026. The sales number gives an early view of TRYNGOLZA’s commercial performance in the U.S. market but does not represent the company’s complete 2025 financial picture.
Ionis Pharmaceuticals reported that partner GSK delivered positive results from two pivotal Phase 3 B-Well studies of bepirovirsen for chronic hepatitis B. The trials, which enrolled over 1,800 patients across 29 countries, met their primary endpoint and showed a statistically significant, clinically meaningful functional cure rate when bepirovirsen was added to standard of care versus standard of care alone, with an acceptable safety profile.
Chronic hepatitis B affects more than 250 million people worldwide and is a leading cause of liver cancer. If approved, bepirovirsen could become the first finite, six‑month therapeutic option and a backbone for future treatment strategies. Under its 2019 licensing agreement with GSK, Ionis is eligible to receive an additional $150 million in regulatory and sales milestone payments and tiered royalties of 10–12% on net sales of bepirovirsen.
Ionis Pharmaceuticals, Inc. completed a private offering of $770.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2030. The zero-coupon notes are unsecured, mature on December 1, 2030, and can be converted into cash, Ionis common stock, or a combination, at the company’s election. The initial conversion rate is 10.1932 shares per $1,000 principal (about $98.10 per share), a roughly 35.0% premium to the November 12, 2025 stock price, with potential rate increases after certain corporate events.
Ionis estimates net proceeds of about $751.2 million. It used approximately $267.6 million to repurchase for cash $200.0 million principal amount of its 0% Convertible Senior Notes due 2026 and plans to use the remaining proceeds for additional repurchases of the 2026 notes and general corporate purposes. Based on the initial maximum conversion rate of 13.7608 shares per $1,000, up to 10,595,816 shares of common stock may initially be issuable upon conversion.
Ionis Pharmaceuticals (IONS) announced pivotal Phase 3 success for olezarsen in severe hypertriglyceridemia. The CORE and CORE2 studies met the primary endpoint, with olezarsen delivering a placebo-adjusted mean reduction in fasting triglycerides of up to 72% at six months, sustained through 12 months. Olezarsen also achieved a highly statistically significant 85% reduction in adjudicated acute pancreatitis events, and 86% of treated patients reached triglyceride levels below 500 mg/dL.
Safety and tolerability were favorable: adverse events were balanced across arms, serious adverse events were less frequent than placebo, and injection-site reactions were the most common events. At 80 mg, asymptomatic liver enzyme elevations ≥3x ULN occurred in 7% vs 2% on placebo, with no Hy’s law cases and events generally resolving on treatment. Results were presented at the American Heart Association Scientific Sessions and published in NEJM. Ionis plans to submit a supplemental new drug application by year-end and expects a PDUFA target action date in 2026.
Ionis Pharmaceuticals (IONS) filed an 8-K/A adding Item 1.01 and attaching an Advisory Services Agreement with Dr. Richard Geary, who will advise the company following his retirement in January 2026. The agreement runs from January 16, 2026 through February 13, 2027 and can be terminated by either party with at least 15 days’ written notice.
Dr. Geary will receive a total fee of $300,000, plus $400 per hour for any hours above 16 in a week, up to six additional hours. Total payments will not exceed $450,000 without prior written authorization.
Ionis Pharmaceuticals (IONS) furnished an 8-K announcing financial results for the quarter ended September 30, 2025. The press release (Exhibit 99.1) presents both GAAP and non-GAAP figures. Non-GAAP results exclude non-cash compensation expense related to equity awards and the related tax effects, which the company says helps users assess and compare performance and project future results and cash flows. The information and exhibit are furnished under Item 2.02 and are not deemed filed under Section 18 of the Exchange Act.
Ionis Pharmaceuticals announced positive topline results from the pivotal study of zilganersen 50 mg in children and adults with Alexander disease (AxD). The drug met the study's primary endpoint: stabilization in gait speed on the 10-Meter Walk Test at week 61, showing a mean difference of 33.3% (p=0.0412) versus control. The company reports consistent benefit across key secondary endpoints related to patient- and clinician-reported measures and says safety and tolerability were favorable, with most adverse events mild or moderate and serious adverse events numerically lower in the zilganersen arm.
Ionis plans to submit a new drug application to the U.S. FDA in Q1 2026 and is evaluating an Expanded Access Program in the U.S. Detailed data will be presented at an upcoming medical conference.
Ionis Pharmaceuticals reported positive topline results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in severe hypertriglyceridemia (sHTG). Across nearly 1,100 patients required to remain on standard-of-care lipid-lowering therapy, olezarsen produced highly statistically significant, placebo-adjusted mean reductions in fasting triglycerides of up to 72% and a highly statistically significant 85% reduction in acute pancreatitis events. Both 80 mg and 50 mg monthly doses met the primary endpoint at six months with strong p-values (p<0.0001), and the company described safety and tolerability as favorable.
Ionis Pharmaceuticals announced that the FDA has approved DAWNZERA (donidalorsen) to prevent hereditary angioedema (HAE) attacks in adults and children 12 and older. DAWNZERA is described as the first and only RNA-targeted medicine approved for HAE, given as an 80 mg self-administered subcutaneous autoinjector every four or eight weeks.
The approval is based on the Phase 3 OASIS-HAE study, where DAWNZERA given every four weeks reduced monthly HAE attack rates by 81% versus placebo over 24 weeks, and by 87% from the second dose. It also cut moderate-to-severe attacks by about 90%. In the OASISplus extension, DAWNZERA showed a 94% mean attack rate reduction from baseline across dosing groups after one year.
In patients switching from other prophylactic treatments, DAWNZERA lowered mean attack rates by 62% over 16 weeks, and 84% of surveyed patients preferred it, citing better disease control and easier administration. The most common side effects were injection site reactions, upper and urinary tract infections, and abdominal discomfort.